“ZyCov-D a Momentous Feat:” PM, One Crore Doses by October: Company

Manas Dasgupta

NEW DELHI, Aug 21: As the Gujarat-based drug company Zydus Cadila – produced the first DNA-based vaccine ‘ZyCov-D’ received the Emergency Use Authorisation from the Drug Controller of India, the prime minister Narendra Modi hailed it as a “momentous feat” and a “testimony to the innovative zeal of India’s scientists.”

“India is fighting Covid-19 with full vigour. The approval for world’s first DNA based ‘ZyCov-D’ vaccine of @ZydusUniverse is a testimony to the innovative zeal of India’s scientists,” Modi tweeted on Saturday, “A momentous feat indeed,” he said hailing the approval of the indigenously developed vaccine.

The Drug firm Zydus Cadila on Saturday said they hoped to produce one crore doses of its vaccine ZyCoV-D by October. It further said the company was hoping to start supplying vaccine doses by the middle to end of September, adding that the pricing of the dose would be announced in the next one or two weeks.

“This is a historic milestone with ZyCoV-D, a product of Indian innovation becoming the world’s first DNA vaccine being offered for human use and supporting the world’s largest immunization drive,” Cadila Healthcare Chairman Pankaj R Patel said.

The company plans to manufacture 10-12 crore doses of ZyCoV-D annually, Zydus Cadila had said in a statement.

“We are particularly happy that our vaccine will contribute to this fight against COVID-19 and enable the country to vaccinate a larger population especially in the age group of 12-18 years.

“I would like to thank all the researchers, clinical trial investigators, volunteers and the regulators who have supported this endeavour,” the Cadila Healthcare chairman had added.

The company’s indigenously developed needle-free three-dose COVID-19 vaccine ZyCoV-D was granted emergency use authorisation (EUA) by the drug regulator on late Friday evening making it the first vaccine to be administered to beneficiaries in the age group of 12-18 years in the country.

“Post the emergency use authorisation, now we will work closely with the regulatory authorities to work on the pricing and modality of delivery of the doses of our vaccine. In next one or two weeks we will have better clarity on the pricing,” Zydus Group Managing Director Sharvil Patel said in a virtual press conference.

The company hopes that “by middle to end of September, we can start supplying the vaccines, and as I said we need to scale up to 1 crore doses and we believe by October we can achieve this. We believe by October we will start producing 1 crore doses and that would mean by end of January, we can have 4 to 5 crore doses,” he added.

Asked if the company was considering partnering with other firms to scale up production of its vaccine, Patel said Zydus Cadila is actively looking at ramping up manufacturing both domestically through partnerships and also outside of the country.

Patel said no severe side-effect associated with the vaccine was seen. “Trials were conducted in 50 centres in the country. Overall, the trials on 28,000 volunteers were conducted. We’ve done the trials on 1400 adolescents of 12-18 yrs. In all the trials, we’ve not seen any severe side effects related to the vaccine,” he said.

“The full phase 3 data doesn’t only showed efficacy but also means safety and long-term immunogenicity which is at least followed up for next 3-6 months. So, for the full report to be published in a peer-reviewed journal will take at least 4-5 months,” he added.

He further said, “We haven’t started studies for the younger age group (2-12 yrs). We’re working with regulators to work on a program to do a study in the younger age group also. We’re going to the regulator with the proposed trial in next 5-7 days. We hope to do trials very soon.” The company is also seeking approval for a two-dose regimen of the vaccine, he added.

ZyCoV-D is the sixth vaccine to get the emergency use authorisation in the country, after Serum Institute of India’s Covishield, Bharat Biotech’s Covaxin, Russian vaccine Sputnik V and the vaccines of Moderna and Johnson and Johnson.

Of these, Covishield, Covaxin and Sputnik V are currently in use in India.

These vaccines are being given to only those above 18 years of age and while ZyCoV-D is for use in adults and children above 12 years, making it potentially the first vaccine to be administered to the adolescent population in India.

ZyCoV-D which has three doses, unlike the other vaccines which are administered in two doses, is set to become the first Covid vaccine candidate developed on a plasmid DNA platform to be commercially introduced anywhere in the world. The vaccine, jointly developed in partnership with the Department of Biotechnology, had demonstrated a primary efficacy of 66.66 per cent in phase 3 clinical trials. It was the first Covid-19 vaccine in India to be tested in the adolescent population — those in the 12-18-year age group.

Meanwhile, India reported 34,457 new cases of coronavirus infections and 375 deaths on Friday, according to data from the Union Health Ministry. Active cases in the country have come down to 3.61 lakh. Out of the new cases, Kerala reported 20,224 cases, and 99 deaths while Maharashtra had 4,365 new infections and 106 fatalities. The total death toll has reached 4.34 lakh.

Maharashtra Chief Minister Uddhav Thackeray on Saturday inaugurated a paediatric COVID-19 care centre in suburban Santacruz. He later said the people should not let their guard down as the threat of a third wave of the COVID-19 pandemic still looms. He said the pandemic was not over yet, and “people should behave responsibly.”

The Delhi chief minister Arvind Kejriwal said restrictions on timings for markets to stay open have been done away with now. “Markets of Delhi were allowed to function till 8 pm due to COVID-19. In wake of decreasing cases, this restriction will be removed starting Monday. Now the markets can open as per their normal time,” he said.